Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy (PRIME CARE)
2026. május 19. frissítette: University of Nebraska
Postpartum Remote Monitoring and Integration of Mobile Health With Engagement From Community Health Workers for Regulating Elevated Blood Pressure
The goal of this randomized clinical trial is to evaluate the effectiveness of a collaborative care intervention, consisting of remote blood pressure monitoring and support from community health workers, in improving blood pressure control and reducing postpartum complications among Black women with hypertensive disorders of pregnancy (HDP).
The primary objectives are to determine whether the intervention leads to improved blood pressure control at 12 months postpartum compared to standard care, and whether it reduces the incidence of serious maternal morbidity, including hospitalizations and cardiovascular events.
Secondary objectives include examining whether patient activation and trust in the healthcare system mediate the relationship between the intervention and clinical outcomes.
Participants will be enrolled at approximately 6 weeks postpartum and randomized to either the collaborative care intervention or standard postpartum care.
All participants will self-monitor blood pressure using a provided device, receive guidance on hypertension management, and complete study assessments at multiple time points.
Participants assigned to the intervention arm will additionally receive ongoing support from community health workers, including health education, care coordination, and assistance with healthcare navigation.
Clinical outcomes and patient-reported measures will be assessed over a 12-month follow-up period.
A tanulmány áttekintése
Állapot
Még nincs toborzás
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
404
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Sajid Shahul, MD, PhD
- Telefonszám: 773-398-2956
- E-mail: sshahul@unmc.edu
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Mridula Ghotane, MPH
- Telefonszám: 445-260-9532
- E-mail: mghotane@unmc.edu
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
Inclusion Criteria:
- Black/ African American patients
- Age: 19 and 50 years of age
- Diagnosis: Hypertension Disorders of Pregnancy
- Enrolled in STAMPP-HTN for first 6 weeks postpartum
Exclusion Criteria:
- Age: <19 years
- Significant Kidney or Liver disease that may limit antihypertensive medication adjustment
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Collaborative Care Intervention
Participants assigned to this arm will receive a collaborative care intervention that includes home blood pressure monitoring using a provided device and support from community health workers.
The intervention includes education on hypertension management, assistance with care coordination, and support with healthcare navigation.
Participants will regularly measure blood pressure and receive ongoing guidance throughout the 12-month postpartum follow-up period.
|
Bluetooth-enabled Remote Patient Monitoring (RPM) with algorithm-driven Community Health Worker (CHW) support.
CHWs provide support (averaging 2.3 contacts/week) to facilitate medication titration and address social determinants of health.
Treatment follows a standardized protocol using guideline-directed medical therapy targeting a blood pressure of <130/80 mmHg.
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Aktív összehasonlító: Standard Postpartum Care
Participants assigned to this arm will receive standard postpartum care.
In addition, participants will be provided with a home blood pressure monitoring device and instructed to measure their blood pressure regularly.
No additional community health worker support will be provided.
|
Traditional clinical management consisting of manual blood pressure monitoring and clinic-based medication titration.
Treatment follows the same standardized protocol as the intervention arm, using guideline-directed medical therapy targeting a blood pressure of <130/80 mmHg.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Blood Pressure Control (BP <130/80 mmHg)
Időkeret: Baseline (6 weeks) postpartum to 12 months postpartum
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Primary endpoint - The proportion of patients achieving a target blood pressure of less than 130/80 mmHg.
Blood pressure will be analyzed both as a dichotomous variable (normal <130/80 mmHg vs. elevated) and as a continuous variable (mean systolic and diastolic readings).
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Baseline (6 weeks) postpartum to 12 months postpartum
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Patient Activation Measure (PAM-13)
Időkeret: At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
|
Evaluation of survey-based mechanisms of action to determine if they mediate the impact of the Collaborative Care intervention on blood pressure outcome.
It assesses patient engagement and activation.
A 13-item survey instrument with scores ranging from a minimum of 0 to a maximum of 100.
Higher scores indicate a better outcome (greater patient engagement and activation).
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At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
|
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Morisky Medication Adherence Scale (MMAS-8)
Időkeret: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
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A survey-based mechanism of action evaluated via an 8-item self-report survey scale to determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome.
It measures medication adherence behavior.
Scores range from a minimum of 0 to a maximum of 8, where higher scores indicate a better outcome (higher medication adherence).
Scores are categorized into low (<6), medium (6 to <8), and high (8) adherence.
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At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
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Trust in Physician Scale
Időkeret: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
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An 11-item exploratory survey instrument used to evaluate trust in the health care system and determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome.
Scores range from a minimum of 11 to a maximum of 55, where higher scores indicate a better outcome (greater trust in the healthcare provider).
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At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
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Severe Maternal Morbidity (SMM) Composite Rate
Időkeret: Baseline (6weeks) postpartum to 12 months (1 year) postpartum
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Composite Endpoint - Incidence rates of severe maternal morbidity events to assess the efficacy of the Collaborative Care model in reducing overall maternal risk.
This composite variable tracks the occurrence of any unplanned emergency department (ED) visit, unplanned hospitalization, or the presence of a severe morbidity event.
Severe morbidity events are strictly defined as the clinical occurrence of severe hypertension, acute heart failure, pulmonary edema, eclampsia, acute renal failure, shock, sepsis, cardiac arrest, arrhythmias, myocardial infarction, pulmonary embolism, stroke, or death.
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Baseline (6weeks) postpartum to 12 months (1 year) postpartum
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Sajid Shahul, MD, PhD, Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
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Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. július 1.
Elsődleges befejezés (Becsült)
2031. június 30.
A tanulmány befejezése (Becsült)
2031. június 30.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. május 8.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 19.
Első közzététel (Tényleges)
2026. május 26.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. május 26.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 19.
Utolsó ellenőrzés
2026. május 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Urogenitális betegségek
- Érrendszeri betegségek
- Szív-és érrendszeri betegségek
- Női urogenitális betegségek és terhességi szövődmények
- Terhességi szövődmények
- Magas vérnyomás
- Magas vérnyomás, terhesség által kiváltott
- Egészségügyi szolgáltatások igazgatása
- Egészségügyi ellátás minősége, hozzáférése és értékelése
- Egészségügyi ellátás minősége
- Minőségi mutatók, egészségügyi ellátás
- Gondozási színvonal
Egyéb vizsgálati azonosító számok
- 0312-26-EP
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .